1. Field of the Invention
The present invention relates to a method for placement of certain medical devices. In particular, it pertains to the placement of electrodes in the field biopotential or electrophysiological monitoring. More particularly, it provides a new method for marking the skin of a subject where medical electrodes are to be placed including the placement of an electrode harness containing these electrodes.
2. Technical Background
Electrodes are used in the medical field for monitoring biopotential of different subjects including patients. Groups of two or more electrodes are commonly used in order to allow for a variety of types of analysis. Such types of analysis include ECG (or EKG), EEG, EMG, and other such biopotential measurements using standard sensors such as electrodes. Many standard EKG measurements such as the commonly performed “stress test” require up to 12 separate electrodes to be placed on the skin of the subject in precise correlation to the patient's anatomical features. For many biopotential measurements, specific anatomical placement of electrodes is required for accurate measurements. In some instances, misplacement of electrodes by as much as a half an inch could lead to faulty measurements and misdiagnosis. Such accurate placement has in the past, and continues to require a highly trained medical specialist such as a doctor or nurse. Availability of one of the aforementioned medical specialists is generally not an issue in an inpatient setting. However, increasing use of “at home” or ambulatory monitoring presents the problem of placing the patient in a monitoring setting where no healthcare professional is available to properly place electrodes.
Generally, an at home monitoring setup is conducted at the hospital where electrodes and accompanying wires or harness are accurately placed on the patient by a healthcare professional. The patient is instructed to wear the electrodes and harness 24 hours a day for in some cases a number of days without removal to ensure that the proper placement of the electrodes is maintained. The patient is also instructed not to bathe during this time period. Periodically, the patient may return for placement of new electrodes.
There is currently a need in the healthcare field for a way to enable ambulatory monitoring of patients that allows for patients or their untrained healthcare providers to properly place monitoring electrodes. There are many factors contributing to this need for ambulatory monitoring. The greatest factor is the high cost of healthcare and especially inpatient care. Hospital stays routinely cost a thousand dollars a day, with intensive care unit (ICU) and cardiac care unit stays greatly elevating this cost. Many healthcare providers and insurance companies consider it a waste of valuable resources and scarce hospital beds to keep an otherwise stable patient in a hospital when their only requirement is medial monitoring.
In the past, the problem with ambulatory monitoring has been its decreased accuracy due to patient compliance with monitoring procedures. Monitored patients routinely violate their doctor's orders by removing their electrodes because they are uncomfortable for mobile activities and do not allow the patient to bathe. Once removed, these electrodes are extremely difficult, if not impossible, for the patient or an untrained healthcare provider to correctly place the electrodes back on. Consequently, the monitoring suffers and the doctor cannot obtain an accurate diagnosis of the patient's medical condition. Therefore, there is a need for a method that allows for accurate placement of medical electrodes and associated harness in an ambulatory setting by a home caregiver or even the patient himself.
It is an object of the present invention to provide a method of marking a subject's skin with a permanent or semi-permanent marking, which allows for any person, untrained in the medical arts, to properly place medical electrodes onto a patient to allow for precise biopotential monitoring. This method yields many advantages to both the patient and the doctor. Hospital stays are reduced leading to lower healthcare costs. Patient quality of life is increased because there are fewer trips to and stays at the hospital and because the patient can properly replace detached electrodes after bathing or other mobile activities. More accurate monitoring is achieved through allowing the patient to remove the monitor for short periods and permitting them to replace it properly. This allows for longer-term monitoring and increases the overall accuracy of monitoring.